Abstract
The coronavirus disease-19 (COVID-19) pandemic promises to have lasting impacts on cancer clinical trials that could lead to faster patient access to new treatments. In this article, an international panel of oncology experts discusses the lasting impacts of the pandemic on oncology clinical trials and proposes solutions for clinical trial stakeholders, with the support of recent data on worldwide clinical trials collected by IQVIA. These lasting impacts and proposed solutions encompass three topic areas. Firstly, acceleration and implementation of new operational approaches to oncology trials with patient-centric, fully decentralized virtual approaches that include remote assessments via telemedicine and remote devices. Geographical differences in the uptake of remote technology, including telemedicine, are discussed in the article, focusing on the impact of the local adoption of new operational approaches. Secondly, innovative clinical trials. The pandemic has highlighted the need for new trial designs that accelerate research and limit risks and burden for patients while driving optimization of clinical trial objectives and endpoints, while testing is being minimized. Areas of considerations for clinical trial stakeholders are discussed in detail. In addition, the COVID-19 pandemic has exposed the underrepresentation of minority groups in clinical trials; the approach for oncology clinical trials to improve generalizability of efficacy and outcomes data is discussed. Thirdly, a new problem-focused collaborative framework between oncology trial stakeholders, including decision makers, to leverage and further accelerate the innovative approaches in clinical research developed during the COVID-19 pandemic. This could shorten timelines for patient access to new treatments by addressing the cultural and technological barriers to adopting new operational approaches and innovative clinical trials. The role of the different stakeholders is described, with the aim of making COVID-19 a catalyst for positive change in oncology clinical research and eventually in cancer care.
| Original language | English (US) |
|---|---|
| Article number | 100339 |
| Journal | ESMO Open |
| Volume | 7 |
| Issue number | 1 |
| DOIs | |
| State | Published - Feb 2022 |
Keywords
- COVID-19
- cancer care
- clinical research
- collaborative framework
- real-world evidence
ASJC Scopus subject areas
- Oncology
- Cancer Research
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The impact of COVID-19 on cancer care and oncology clinical research : an experts’ perspective. / Sessa, C.; Cortes, J.; Conte, P. et al.
In: ESMO Open, Vol. 7, No. 1, 100339, 02.2022.Research output: Contribution to journal › Review article › peer-review
}
TY - JOUR
T1 - The impact of COVID-19 on cancer care and oncology clinical research
T2 - an experts’ perspective
AU - Sessa, C.
AU - Cortes, J.
AU - Conte, P.
AU - Cardoso, F.
AU - Choueiri, T.
AU - Dummer, R.
AU - Lorusso, P.
AU - Ottmann, O.
AU - Ryll, B.
AU - Mok, T.
AU - Tempero, M.
AU - Comis, S.
AU - Oliva, C.
AU - Peters, S.
AU - Tabernero, J.
N1 - Funding Information: BR: Consultancy: Amgen, AstraZeneca, BMS, Celgene, Clinigen, IQVIA, MSD, Novartis, Pfizer and Roche (personal fees). FC: Consultancy role for: Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, Macrogenics, Medscape, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre Fabre, prIME Oncology, Roche, Sanofi, Samsung Bioepis, Seagen and Teva. Local PI, institutional, financial interest: Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi, Eisai, Fresenius GmbH, Genentech, GlaxoSmithKline, Incyte, Ipsen, Macrogenics, Medigene, MedImmune, Merck, Millenium, Nektar Therapeutics, Nerviano, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi-Aventis, Sonus, Taiho Oncology, Tesaro, Tigris, Wilex and Wyeth. JC: Research support to institution: Novartis, Pfizer, Takeda, Sun Pharma, Kartos, Jazz Pharma, Actuate, Abbvie and Biopath Holdings. Consulting from Novartis, Pfizer, Takeda, Sun Pharma, Jazz Pharma, Abbvie and Biopath Holdings. JT: Scientific consultancy role for Array Biopharma, AstraZeneca, Avvinity, Bayer, Boehringer Ingelheim, Chugai, Daiichi Sankyo, F. Hoffmann-La Roche Ltd, Genentech Inc, HalioDX SAS, Hutchison MediPharma International, Ikena Oncology, IQVIA, Lilly, Menarini, Merck Serono, Merus, MSD, Mirati, Neophore, Novartis, Orion Biotechnology, Peptomyc, Pfizer, Pierre Fabre, Samsung Bioepis, Sanofi, Seattle Genetics, Servier, Taiho, Tessa Therapeutics and TheraMyc. Educational collaboration with Imedex, Medscape Education, MJH Life Sciences, PeerView Institute for Medical Education and Physicians Education Resource (PER). Clinical trials or contracted research for Amgen Inc, Array Biopharma Inc, AstraZeneca Pharmaceuticals LP, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Debiopharm International SA, F. Hoffmann-La Roche Ltd, Genentech Inc, HalioDX SAS, Hutchison MediPharma International, Janssen-Cilag SA, MedImmune, Menarini, Merck Health KGAA, Merck Sharp & Dohme, Merus NV, Mirati, Novartis Farmacéutica SA, Pfizer, Pharma Mar, Sanofi Aventis Recherche & Développement, Servier, Taiho Pharma USA Inc, Spanish Association Against Cancer Scientific Foundation and Cancer Research UK (fees to institution). MT: Data Safety Monitoring Committee: Astellas Pharma Global Development, Inc. Grant support: Celgene and Halozyme. Advisory board: Abbvie, AstraZeneca, Biotech Research, Boehriner Ingelheim, Bristol Myers Squibb, Corcept Therapeutics, Geistlich Pharma, GlaxoSmithKline, LLC, Merck & Co., Inc., Seagen, Inc. and Swedish Orphan Biovitrum. Consultant: ISPEN, Inc., Incyte, Karyopharm Therapeutics and Novartis Pharmaceuticals. OO: Research funding: Incyte, Amgen and Celgene. Honoraria: Incyte, Takeda, Amgen, Celgene, Novartis, Roche, Fusion Pharma and IQVIA. Membership on an entity’s board of directors or advisory committees: Incyte, Amgen, Celgene, Novartis, Roche and Fusion Pharma. PC: Consulting or advisory role: Daiichi Sankyo/Lilly. Speakers’ bureau: Roche/Genentech, Novartis, AstraZeneca, Eli Lilly, Tesaro and BMS. Research funding: Roche, Novartis, Merck KGaA and BMS (fees paid to institution). Expert testimony: Roche and AstraZeneca. Travel, accommodations, expenses: Novartis, Celgene, AstraZeneca and Pfizer. PL: Advisory board member: Abbvie, GenMab, Genentech, CytomX, Takeda, Cybrexa, Agenus, IQVIA, TRIGR, Pfizer, ImmunoMet, Black Diamond, Glaxo-Smith Kline, QED Therapeutics, AstraZeneca, EMD Serono, Shattuck, Astellas, Salarius, Silverback, MacroGenics, Kyowa Kirin Pharmaceutical Development, Kineta, Inc., Zentalis Pharmaceuticals, Molecular Templates, ABL Bio, STCube Pharmaceuticals, Bayer and I-Mab. Data Safety Monitoring Board: Agios and Halozyme. Data Safety Monitoring Committee: Five Prime and Tyme. ImCORE Alliance: Roche-Genentech. Consultant: Sotio, SK Life Science and I-Mab. RD: Intermittent, project focused consulting and/or advisory relationships with Novartis, Merck Sharp & Dohme (MSD), Bristol Myers Squibb (BMS), Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome, Regeneron, Alligator, T3 Pharma, MaxiVAX SA, Pfizer and touchIME outside the submitted work. SP: Consultation/advisory role: AbbVie, Amgen, AstraZeneca, Bayer, Beigene, Biocartis, Boehringer Ingelheim, Bristol Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, ecancer, Eli Lilly, Elsevier, Foundation Medicine, Illumina, Imedex, IQVIA, Incyte, Janssen, Medscape, Merck Sharp and Dohme, Merck Serono, Merrimack, Novartis, Pharma Mar, Phosplatin Therapeutics, PER, Pfizer, PRIME, Regeneron, Roche/Genentech, RTP, Sanofi, Seattle Genetics and Takeda. Talk in a company’s organized public event: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, ecancer, Eli Lilly, Illumina, Imedex, Medscape, Merck Sharp and Dohme, Novartis, PER, Pfizer, Prime, Roche/Genentech, RTP, Sanofi and Takeda. Receipt of grants/research supports: (Sub)investigator in trials (institutional financial support for clinical trials) sponsored by Amgen, AstraZeneca, Biodesix, Boehringer Ingelheim, Bristol Myers Squibb, Clovis, GSK, Illumina, Lilly, Merck Sharp and Dohme, Merck Serono, Mirati, Novartis, Pfizer, Phosplatin Therapeutics and Roche/Genentech. All fees to institution. TC: Research/advisory boards/consultancy/honorarium (institutional and personal): AstraZeneca, Aravive, Aveo, Bayer, Bristol Myers Squibb, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, IQVA, Ipsen, Kanaph, Lilly, Merck, Nikang, Novartis, Pfizer, Roche, Sanofi/Aventis, Takeda, Tempest, Up-To-Date and CME events (Peerview, OncLive and others). Supported in part by the Dana-Farber/Harvard Cancer Center Kidney SPORE and Program, the Kohlberg Chair at Harvard Medical School and the Trust Family, Michael Brigham and Loker Pinard Funds for Kidney Cancer Research at DFCI. TM: Honoraria for speaker, consultancy or advisory role: AstraZeneca, AbbVie, ACEA Pharma, Alpha Biopharma, Amgen, Amoy Diagnostics, BeiGene, BI, Bristol Myers Squibb, Eli Lilly, Blueprint Medicines, Berry Oncology, CStone Pharma, Daiichi Sankyo, Fishawack Facilitate, Eisai, Gritstone Oncology, Guardant Health, G1 Therapeutics, Hengrui, Ignyta, IQVIA, Incyte Corporation, Inivata, InMed Medical Communication, Lucence Health Inc, Janssen, Loxo-Oncology, Qiming Dev., Lunit USA, Inc, Merck Serono, MSD, Roche, LiangyiHui Co., MD Health, Medscape/WebMD, Mirati Therapeutics, MoreHealth, Novartis, OrigiMed, Puma Tech, PeerVoice, PER, Permanyer SL, Prime Oncology, Research to Practice, Touch Medical Media, Shanghai BeBirds, Sanofi-Aventis, Takeda, Virtus Medical, Yuhan and Curio Science. Leadership role/board of directors: Sanomics Ltd., Hutchinson Chi-Med, AstraZeneca, Aurora Tele-Oncology, and Lunit USA, Inc. Stocks or ownership interest: Sanomics Ltd., Hutchinson Chi-Med, Biolidics Ltd., Loxo-Oncology, OrigiMed Co., Virtus Medical Group and Lunit USA, Inc. Clinical trials: AstraZeneca, BMS, Merck Serono, MSD, Novartis, Pfizer, Roche, SFJ Pharmaceuticals, XCovery, Takeda, G1 Therapeutics and Clovis Oncology (fees to institution). The remaining authors have declared no conflicts of interest. Funding Information: The authors thank Jill Dawson, PhD, for medical writing assistance. None declared. BR: Consultancy: Amgen, AstraZeneca, BMS, Celgene, Clinigen, IQVIA, MSD, Novartis, Pfizer and Roche (personal fees). FC: Consultancy role for: Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, Macrogenics, Medscape, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre Fabre, prIME Oncology, Roche, Sanofi, Samsung Bioepis, Seagen and Teva. Local PI, institutional, financial interest: Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi, Eisai, Fresenius GmbH, Genentech, GlaxoSmithKline, Incyte, Ipsen, Macrogenics, Medigene, MedImmune, Merck, Millenium, Nektar Therapeutics, Nerviano, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi-Aventis, Sonus, Taiho Oncology, Tesaro, Tigris, Wilex and Wyeth. JC: Research support to institution: Novartis, Pfizer, Takeda, Sun Pharma, Kartos, Jazz Pharma, Actuate, Abbvie and Biopath Holdings. Consulting from Novartis, Pfizer, Takeda, Sun Pharma, Jazz Pharma, Abbvie and Biopath Holdings. JT: Scientific consultancy role for Array Biopharma, AstraZeneca, Avvinity, Bayer, Boehringer Ingelheim, Chugai, Daiichi Sankyo, F. Hoffmann-La Roche Ltd, Genentech Inc, HalioDX SAS, Hutchison MediPharma International, Ikena Oncology, IQVIA, Lilly, Menarini, Merck Serono, Merus, MSD, Mirati, Neophore, Novartis, Orion Biotechnology, Peptomyc, Pfizer, Pierre Fabre, Samsung Bioepis, Sanofi, Seattle Genetics, Servier, Taiho, Tessa Therapeutics and TheraMyc. Educational collaboration with Imedex, Medscape Education, MJH Life Sciences, PeerView Institute for Medical Education and Physicians Education Resource (PER). Clinical trials or contracted research for Amgen Inc, Array Biopharma Inc, AstraZeneca Pharmaceuticals LP, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Debiopharm International SA, F. Hoffmann-La Roche Ltd, Genentech Inc, HalioDX SAS, Hutchison MediPharma International, Janssen-Cilag SA, MedImmune, Menarini, Merck Health KGAA, Merck Sharp & Dohme, Merus NV, Mirati, Novartis Farmac?utica SA, Pfizer, Pharma Mar, Sanofi Aventis Recherche & D?veloppement, Servier, Taiho Pharma USA Inc, Spanish Association Against Cancer Scientific Foundation and Cancer Research UK (fees to institution). MT: Data Safety Monitoring Committee: Astellas Pharma Global Development, Inc. Grant support: Celgene and Halozyme. Advisory board: Abbvie, AstraZeneca, Biotech Research, Boehriner Ingelheim, Bristol Myers Squibb, Corcept Therapeutics, Geistlich Pharma, GlaxoSmithKline, LLC, Merck & Co. Inc. Seagen, Inc. and Swedish Orphan Biovitrum. Consultant: ISPEN, Inc. Incyte, Karyopharm Therapeutics and Novartis Pharmaceuticals. OO: Research funding: Incyte, Amgen and Celgene. Honoraria: Incyte, Takeda, Amgen, Celgene, Novartis, Roche, Fusion Pharma and IQVIA. Membership on an entity's board of directors or advisory committees: Incyte, Amgen, Celgene, Novartis, Roche and Fusion Pharma. PC: Consulting or advisory role: Daiichi Sankyo/Lilly. Speakers? bureau: Roche/Genentech, Novartis, AstraZeneca, Eli Lilly, Tesaro and BMS. Research funding: Roche, Novartis, Merck KGaA and BMS (fees paid to institution). Expert testimony: Roche and AstraZeneca. Travel, accommodations, expenses: Novartis, Celgene, AstraZeneca and Pfizer. PL: Advisory board member: Abbvie, GenMab, Genentech, CytomX, Takeda, Cybrexa, Agenus, IQVIA, TRIGR, Pfizer, ImmunoMet, Black Diamond, Glaxo-Smith Kline, QED Therapeutics, AstraZeneca, EMD Serono, Shattuck, Astellas, Salarius, Silverback, MacroGenics, Kyowa Kirin Pharmaceutical Development, Kineta, Inc. Zentalis Pharmaceuticals, Molecular Templates, ABL Bio, STCube Pharmaceuticals, Bayer and I-Mab. Data Safety Monitoring Board: Agios and Halozyme. Data Safety Monitoring Committee: Five Prime and Tyme. ImCORE Alliance: Roche-Genentech. Consultant: Sotio, SK Life Science and I-Mab. RD: Intermittent, project focused consulting and/or advisory relationships with Novartis, Merck Sharp & Dohme (MSD), Bristol Myers Squibb (BMS), Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome, Regeneron, Alligator, T3 Pharma, MaxiVAX SA, Pfizer and touchIME outside the submitted work. SP: Consultation/advisory role: AbbVie, Amgen, AstraZeneca, Bayer, Beigene, Biocartis, Boehringer Ingelheim, Bristol Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, ecancer, Eli Lilly, Elsevier, Foundation Medicine, Illumina, Imedex, IQVIA, Incyte, Janssen, Medscape, Merck Sharp and Dohme, Merck Serono, Merrimack, Novartis, Pharma Mar, Phosplatin Therapeutics, PER, Pfizer, PRIME, Regeneron, Roche/Genentech, RTP, Sanofi, Seattle Genetics and Takeda. Talk in a company's organized public event: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, ecancer, Eli Lilly, Illumina, Imedex, Medscape, Merck Sharp and Dohme, Novartis, PER, Pfizer, Prime, Roche/Genentech, RTP, Sanofi and Takeda. Receipt of grants/research supports: (Sub)investigator in trials (institutional financial support for clinical trials) sponsored by Amgen, AstraZeneca, Biodesix, Boehringer Ingelheim, Bristol Myers Squibb, Clovis, GSK, Illumina, Lilly, Merck Sharp and Dohme, Merck Serono, Mirati, Novartis, Pfizer, Phosplatin Therapeutics and Roche/Genentech. All fees to institution. TC: Research/advisory boards/consultancy/honorarium (institutional and personal): AstraZeneca, Aravive, Aveo, Bayer, Bristol Myers Squibb, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, IQVA, Ipsen, Kanaph, Lilly, Merck, Nikang, Novartis, Pfizer, Roche, Sanofi/Aventis, Takeda, Tempest, Up-To-Date and CME events (Peerview, OncLive and others). Supported in part by the Dana-Farber/Harvard Cancer Center Kidney SPORE and Program, the Kohlberg Chair at Harvard Medical School and the Trust Family, Michael Brigham and Loker Pinard Funds for Kidney Cancer Research at DFCI. TM: Honoraria for speaker, consultancy or advisory role: AstraZeneca, AbbVie, ACEA Pharma, Alpha Biopharma, Amgen, Amoy Diagnostics, BeiGene, BI, Bristol Myers Squibb, Eli Lilly, Blueprint Medicines, Berry Oncology, CStone Pharma, Daiichi Sankyo, Fishawack Facilitate, Eisai, Gritstone Oncology, Guardant Health, G1 Therapeutics, Hengrui, Ignyta, IQVIA, Incyte Corporation, Inivata, InMed Medical Communication, Lucence Health Inc, Janssen, Loxo-Oncology, Qiming Dev. Lunit USA, Inc, Merck Serono, MSD, Roche, LiangyiHui Co. MD Health, Medscape/WebMD, Mirati Therapeutics, MoreHealth, Novartis, OrigiMed, Puma Tech, PeerVoice, PER, Permanyer SL, Prime Oncology, Research to Practice, Touch Medical Media, Shanghai BeBirds, Sanofi-Aventis, Takeda, Virtus Medical, Yuhan and Curio Science. Leadership role/board of directors: Sanomics Ltd. Hutchinson Chi-Med, AstraZeneca, Aurora Tele-Oncology, and Lunit USA, Inc. Stocks or ownership interest: Sanomics Ltd. Hutchinson Chi-Med, Biolidics Ltd. Loxo-Oncology, OrigiMed Co. Virtus Medical Group and Lunit USA, Inc. Clinical trials: AstraZeneca, BMS, Merck Serono, MSD, Novartis, Pfizer, Roche, SFJ Pharmaceuticals, XCovery, Takeda, G1 Therapeutics and Clovis Oncology (fees to institution). The remaining authors have declared no conflicts of interest. Publisher Copyright: © 2021 The Authors
PY - 2022/2
Y1 - 2022/2
N2 - The coronavirus disease-19 (COVID-19) pandemic promises to have lasting impacts on cancer clinical trials that could lead to faster patient access to new treatments. In this article, an international panel of oncology experts discusses the lasting impacts of the pandemic on oncology clinical trials and proposes solutions for clinical trial stakeholders, with the support of recent data on worldwide clinical trials collected by IQVIA. These lasting impacts and proposed solutions encompass three topic areas. Firstly, acceleration and implementation of new operational approaches to oncology trials with patient-centric, fully decentralized virtual approaches that include remote assessments via telemedicine and remote devices. Geographical differences in the uptake of remote technology, including telemedicine, are discussed in the article, focusing on the impact of the local adoption of new operational approaches. Secondly, innovative clinical trials. The pandemic has highlighted the need for new trial designs that accelerate research and limit risks and burden for patients while driving optimization of clinical trial objectives and endpoints, while testing is being minimized. Areas of considerations for clinical trial stakeholders are discussed in detail. In addition, the COVID-19 pandemic has exposed the underrepresentation of minority groups in clinical trials; the approach for oncology clinical trials to improve generalizability of efficacy and outcomes data is discussed. Thirdly, a new problem-focused collaborative framework between oncology trial stakeholders, including decision makers, to leverage and further accelerate the innovative approaches in clinical research developed during the COVID-19 pandemic. This could shorten timelines for patient access to new treatments by addressing the cultural and technological barriers to adopting new operational approaches and innovative clinical trials. The role of the different stakeholders is described, with the aim of making COVID-19 a catalyst for positive change in oncology clinical research and eventually in cancer care.
AB - The coronavirus disease-19 (COVID-19) pandemic promises to have lasting impacts on cancer clinical trials that could lead to faster patient access to new treatments. In this article, an international panel of oncology experts discusses the lasting impacts of the pandemic on oncology clinical trials and proposes solutions for clinical trial stakeholders, with the support of recent data on worldwide clinical trials collected by IQVIA. These lasting impacts and proposed solutions encompass three topic areas. Firstly, acceleration and implementation of new operational approaches to oncology trials with patient-centric, fully decentralized virtual approaches that include remote assessments via telemedicine and remote devices. Geographical differences in the uptake of remote technology, including telemedicine, are discussed in the article, focusing on the impact of the local adoption of new operational approaches. Secondly, innovative clinical trials. The pandemic has highlighted the need for new trial designs that accelerate research and limit risks and burden for patients while driving optimization of clinical trial objectives and endpoints, while testing is being minimized. Areas of considerations for clinical trial stakeholders are discussed in detail. In addition, the COVID-19 pandemic has exposed the underrepresentation of minority groups in clinical trials; the approach for oncology clinical trials to improve generalizability of efficacy and outcomes data is discussed. Thirdly, a new problem-focused collaborative framework between oncology trial stakeholders, including decision makers, to leverage and further accelerate the innovative approaches in clinical research developed during the COVID-19 pandemic. This could shorten timelines for patient access to new treatments by addressing the cultural and technological barriers to adopting new operational approaches and innovative clinical trials. The role of the different stakeholders is described, with the aim of making COVID-19 a catalyst for positive change in oncology clinical research and eventually in cancer care.
KW - COVID-19
KW - cancer care
KW - clinical research
KW - collaborative framework
KW - real-world evidence
UR - http://www.scopus.com/inward/record.url?scp=85122516651&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85122516651&partnerID=8YFLogxK
U2 - 10.1016/j.esmoop.2021.100339
DO - 10.1016/j.esmoop.2021.100339
M3 - Review article
C2 - 34953404
AN - SCOPUS:85122516651
SN - 2059-7029
VL - 7
JO - ESMO Open
JF - ESMO Open
IS - 1
M1 - 100339
ER -